多塔利单抗(Dostarlimab-gxly) - 药物靶点：PD-1_在研适应症：晚期子宫内膜癌，复发性子宫内膜癌，MSI-H 实体瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Dostarlimab、Dostarlimab subcutaneous injection(Tesaro)、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer

+ [12]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [9]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MSI-H 实体瘤+ [77]

非在研适应症

晚期胆管癌晚期非小细胞肺癌透明细胞肉瘤+ [7]

原研机构

AnaptysBio, Inc.

在研机构

Tesaro, Inc.

GSK PlcGlaxoSmithKline Research & Development Ltd.

+ [6]

非在研机构-

权益机构

AnaptysBio, Inc.Sagard Healthcare Royalty Partners LP

GSK Plc

+ [1]

最高研发阶段批准上市

首次获批日期

欧盟 (2021-04-21),

错配修复缺陷子宫内膜癌

最高研发阶段(中国)临床3期

特殊审评快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)、优先审评 (美国)、局长国家优先审评券 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

113

项与多塔利单抗相关的临床试验

NCT07740720

/ Not yet recruiting临床3期

A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery. Scans and endoscopy tests will be conducted to see if the tumor disappears and how long the cancer stays under control. The study will also collect information on side effects and health outcomes after dostarlimab.

开始日期2026-09-17

申办/合作机构

GSK Plc

NCT07684599

/ Not yet recruiting临床3期

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

The purpose of this study is to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of care and will help us better understand its impact on Health-Related Quality of Life of participants.

开始日期2026-09-03

申办/合作机构

GSK Plc

NCT07652515

/ Not yet recruiting临床4期

Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer

This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).

开始日期2026-08-17

申办/合作机构

GSK Plc

100 项与多塔利单抗相关的临床结果

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100 项与多塔利单抗相关的转化医学

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100 项与多塔利单抗相关的专利（医药）

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226

项与多塔利单抗相关的文献（医药）

2026-12-31·PLATELETS

Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case

Article

作者: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Fernández-Sánchez, Adolfo ; Reguera-Puertas, Pablo ; Puerta-Vázquez, Carlos

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 10⁹/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.

2026-09-01·CANCER LETTERS

Frontline immunotherapy and immune cold reprogramming across molecular subtypes of advanced endometrial cancer

Review

作者: Li, Chia-Jung ; Wen, Zhi-Hong ; Raj, Emmanuel Naveen ; Cheng, Shih-Hsuan ; Lin, Pei-Hsuan ; Sheu, Jim Jinn-Chyuan ; Chiang, An-Jen ; Chang, Renin

The management of endometrial cancer (EC) has transitioned from a histopathological model to a framework based on molecular precision. This change is centered on the integration of immune checkpoint inhibitors, which has altered clinical standards for different genomic subsets. For patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, PD-1 and PD-L1 blockade has moved from late-line therapy to a frontline standard. Results from the RUBY and NRG-GY018 trials show that combining dostarlimab or pembrolizumab with platinum-based chemotherapy improves survival in patients with untreated advanced disease. Mismatch repair proficient (pMMR) tumors, which make up the majority of cases, remain difficult to treat due to an immune-cold microenvironment. Overcoming this resistance requires combination strategies, such as using anti-angiogenic agents like lenvatinib with immune checkpoint inhibitors, as shown in the KEYNOTE-775 trial. Data from the DUO-E study also suggest that including DNA damage response inhibitors may improve results in pMMR populations. As molecular monitoring via liquid biopsy and the use of antibody-drug conjugates (ADCs) evolve, the personalization of immunotherapy continues to progress. This review examines current clinical evidence and the mechanisms of resistance to define the future of precision medicine in endometrial cancer.

2026-08-03·CLINICAL CANCER RESEARCH

A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer

Article

作者: Buza, Natalia ; Greenman, Michelle ; Hui, Pei ; McNamara, Blair ; Papatla, Katyayani ; Ettorre, Victoria M. ; Clark, Mitchell ; Ratner, Elena ; Roque, Dana M. ; Santin, Alessandro D. ; Siegel, Eric R. ; Bellone, Stefania ; Dottino, Peter ; Kailasam, Aparna

Abstract:

Purpose::

Patients with endometrial cancer who progress after chemotherapy/immunotherapy have limited treatment options. We evaluated the activity and safety of sacituzumab govitecan (SG), a Trop-2–directed antibody–drug conjugate, in patients with advanced/recurrent endometrial cancer, including carcinosarcoma.

Patients and Methods::

This was a phase II, two-stage, open-label, investigator-initiated trial of patients with persistent/recurrent endometrial cancer who had progressed following ≥1 prior chemotherapy. Patients received SG 10 mg/kg on days 1 and 8 every 3 weeks. The primary endpoint was objective response rate (ORR) by RECIST v1.1. Secondary endpoints included clinical benefit rate [CBR = complete response (CR) + partial response (PR) + stable disease ≥ 6 months], duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. Trop-2 expression was analyzed by immunohistochemistry as an H-score.

Results::

Fifty patients were screened, and 21 enrolled during stage 1; 34 patients were screened, and 29 enrolled during stage 2; 84% (n = 42) of the patients harbored serous carcinoma, carcinosarcoma, or grade 3 endometrioid tumors. Patients received a median of two prior therapies (range, 1–4) and 50% had failed pembrolizumab/dostarlimab. At a median follow-up (range) of 11 (2.9–65.5) months, the ORR was 28% [95% confidence interval (CI), 16%–42%], including CRs (4%) and PRs (24%). The median DOR (95% CI) was 9.3 (2–12.9) months, with four still responding. The CBR was 52% (26/50). The median PFS and OS were 5.5 (95% CI, 3.7–7.4) and 17.5 (95% CI, 10.4–22.2) months, respectively. Grade 3 to 4 toxicity occurred in 88% with no attributable deaths. Mean H-scores did not predict response.

Conclusions::

SG demonstrated encouraging efficacy in a pretreated population that included biologically aggressive recurrent endometrial cancer. Adverse events were consistent with the known safety profile.

691

项与多塔利单抗相关的新闻（医药）

2026-09-03

·BioSpace

GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy

iStock, Nuthawut Somsuk For $110 million upfront, GSK will have the exclusive global right to advance HMPL-A830, which combines an EGFR-targeting antibody with a small-molecule KRAS blocker. The asset will be studied for colorectal, pancreatic and lung cancer. GSK continues to look eastward for novel assets, this time partnering with Hong Kong-based HUTCHMED to develop an investigational cancer therapy. The deal includes a $110 million upfront payment from the pharma, which could also be on the hook for up to $1.185 billion in development, regulatory and commercial milestones, according to a Thursday announcement . HUTCHMED, which also has offices in mainland China and the U.S., will additionally be eligible for royalties on net sales. The star of Thursday’s deal is HMPL-A830, an investigational asset that combines an EGFR-targeting monoclonal antibody with a small-molecule payload designed to inhibit the KRAS protein. This construct, which HUTCHMED calls an antibody-targeted therapy conjugate (ATTC), allows for “synergistic anti-tumor activity,” according to the news release. “The dual KRAS-EGFR mechanism of HMPL-A830 has the potential to significantly improve upon current standard of care,” Hesham Abdullah, global head of Oncology R&D at GSK, said in a prepared statement. The partners will focus initial development efforts on colorectal, pancreatic and lung cancers, with HUTCHMED taking responsibility over Phase 1 studies. Thereafter, GSK will take over all subsequent clinical development. GSK will have worldwide rights over the development and commercialization of HMPL-A830, except for in mainland China, Hong Kong, Macau and Taiwan, where HUTCHMED retains full control over the asset. The HUTCHMED deal adds to GSK’s growing roster of Asian partners. In January, the pharma paid $20 million upfront and promised up to $265 million in milestones to tie up with South Korea’s Alteogen, gaining access to technology that would allow GSK to create an under-the-skin formulation of its cancer drug Jemperli. Then, in June, the British pharma ponied up $1 billion to swallow China’s Siran Biotechnology, an RNA specialist with an investigational long-acting siRNA therapy called SA030 being positioned as a weight loss therapy. Weight loss GSK goes beyond weight-loss with $1B buyout of Chinese siRNA specialist With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities. May 7, 2026 · 2 min read · Tristan Manalac Read more GSK has also inked several other deals this year, including the $2.2 billion takeover of allergy player RAPT Therapeutics in January, which marked CEO Luke Miels’ first major pickup since becoming the company’s top executive in September 2025. In June, GSK acquired Nuvalent Bio, developer of precision oncology assets, for $10.6 billion —a deal that ranks among 2026’s largest so far . Mergers & acquisitions Biopharma strikes 50+ M&As deals in H1, led by Lilly’s $25B spend The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back. July 1, 2026 · 1 min read · Annalee Armstrong Read more

并购引进/卖出临床1期抗体药物偶联物

2026-09-02

·allsci.com

Novartis taps Alteogen in USD 3.2b subcutaneous biologics pact

Novartis has entered an option and license agreement with South Korea-based Alteogen Inc. (KOSDAQ: 196170) to develop and commercialize subcutaneous formulations of multiple Novartis biologics using ALT-B4 (berahyaluronidase alfa), the recombinant human hyaluronidase at the core of Alteogen's Hybrozyme platform. If all options are exercised and all milestones achieved, Alteogen said it would be eligible to receive up to USD 3.223 billion, including option exercise fees, development and commercial milestones, and royalties on net sales. The deal is structured as a tiered option-and-license arrangement: Novartis holds multiple options, each of which, upon exercise, converts into an exclusive license to develop and commercialize a specific product using ALT-B4. No upfront payment figure was separately disclosed; the company said the total includes option exercise fees, though individual amounts were not broken out. Royalties on net sales are confirmed but undisclosed. The USD 3.223 billion ceiling is one of Alteogen's largest single ALT-B4 deals to date. The company described it as its fourth licensing agreement signed in 2026. The three preceding 2026 deals — with Tesaro (a GSK subsidiary) for subcutaneous dostarlimab at up to USD 285 million, with Biogen for two biologic products, and with an undisclosed global pharma company for a single asset at up to USD 365 million — each covered one or two products. The Novartis deal's USD 3.223 billion ceiling, benchmarked against the approximately USD 365 million per-product ceiling established in August, implies coverage of a broad product slate. ALT-B4 works by transiently depolymerizing hyaluronan in the subcutaneous extracellular matrix, facilitating dispersion and absorption of co-administered biologics. The technology competes directly with Halozyme Therapeutics' rHuPH20 (ENHANZE platform), which underpins more than a dozen approved subcutaneous products. ALT-B4 received its first regulatory validation when the US FDA approved a subcutaneous formulation of pembrolizumab using the enzyme in 2025. In June 2026, Alteogen presented preclinical data at the World ADC Summit showing enhanced systemic exposure and an improved safety profile for ALT-B4-enabled subcutaneous ADC delivery, extending the platform's potential scope. In May 2026, the US Patent Trial and Appeal Board rejected Halozyme's petition to invalidate Alteogen's recombinant hyaluronidase manufacturing patent, and the European Patent Office indicated intent to grant a substance patent covering ALT-B4 the same month. Three of Alteogen's four 2026 deals followed that resolution. Spot something wrong? Report an issue with this article

引进/卖出上市批准专利侵权

2026-08-31

·珐成浩鑫

【P村情报】一周生物 “药” 闻（2026.8.24--8.28）

NEWS（8.24-8.28） //// 【P村情报】是珐成浩鑫诚意推出的资讯板块。我们汇总生物医药行业一周的重要新闻，帮助各位看官梳理热点、把握趋势，了解行业最新动向。 8/24 ■ 23亿美元，基因泰克引进一款潜在FIC减肥药韩美药业（Hanmi Pharmaceuticals）宣布与基因泰克达成许可协议，将新型减重候选药物HM17321在韩国以外的全球开发、生产和商业化权益授予后者。韩美药业已于2025年10月在美国启动HM17321的I期临床试验，在完成I期临床试验之后，基因泰克将接手开发。■ 全球首个乙肝功能性治愈新药获批上市葛兰素史克（GSK）宣布慢性乙肝新药Bepirovirsen（贝普若韦生）在日本获批上市，用于作为慢性乙型肝炎病毒（CHB）感染者的功能性治愈方案，适用于既往接受过至少6个月核苷（酸）类似物治疗且符合病毒标志物标准的成人CHB感染者。该药物是首款实现慢性乙肝功能性治愈的药物。今年5月，该药物在国内递交上市申请。 ■ 首个，GSK PD-1单抗新适应症获得FDA优先审评葛兰素史克（GSK）宣布Dostarlimab（商品名：Jemperli）的补充生物制品许可申请（sBLA）获得FDA优先审评，用于治疗未接受过治疗且存在错配修复缺陷（dMMR）或微卫星不稳定性高（MSI-H）的II/III期局部晚期直肠癌。PDUFA日期定为2027年2月。值得一提的是，该药物还在2025年11月进入了FDA特批药物名单（见：1-2个月内批准！第二批“FDA特批药物”名单公布），因此有可能提前获批上市。 ■ 已启动头对头III期临床！石药EGFR ADC拟纳入突破性疗法 CDE网站显示，石药集团的SYS6010拟纳入突破性疗法，用于单药治疗经EGFR-TKI和含铂化疗治疗失败的复发或转移性头颈部鳞癌患者。SYS6010是石药集团旗下子公司巨石生物自主研发的一款EGFR ADC。临床前研究显示，SYS6010呈剂量依赖性地抑制免疫缺陷小鼠中具有各种EGFR激活突变或野生型EGFR高表达的人类肿瘤的生长。SYS6010尤其在含有针对第三代EGFR-TKI奥希替尼耐药的EGFR三重突变（Exon19Del、T790M及C797S）的人源化非小细胞肺癌PDX模型中显示出很强的抗肿瘤效果。临床前毒理学和安全药理学研究显示，SYS6010具有良好的安全性和耐受性。 ■ 全化疗阶段提供骨髓保护！先声药业「曲拉西利」获批新适应症先声药业宣布科赛拉®（注射用盐酸曲拉西利）新适应症获得国家药监局（NMPA）批准上市，用于复发广泛期小细胞肺癌（SCLC）患者，在接受含拓扑替康方案治疗前给药，以降低化疗引起的骨髓抑制的发生率。至此，科赛拉®的适应症覆盖广泛期小细胞肺癌全化疗阶段的骨髓保护，是国内唯一获批完整覆盖广泛期小细胞肺癌一线、二/三线化疗全治疗周期的骨髓保护药物。 ■ 诺华重磅核药在华申请地产化生产 CDE网站显示，诺华的核药产品镥[177Lu]特昔维匹肽在国内递交地产化生产申请。同日，该药物的两项适应症拟纳入优先审评，可能对应的是本次地产化生产申请。镥[177Lu]特昔维匹肽（177Lu-PSMA-617）是诺华收购Endocyte获得的一款放射配体疗法（RLT），由靶向PSMA的小分子化合物与治疗性放射性核素镥177偶联而成。进入血液后，镥[177Lu]特昔维匹肽与表达PSMA的前列腺癌细胞结合，随后放射性核素释放的辐射能量会损伤靶细胞及周围肿瘤细胞，破坏其DNA复制能力和/或引发肿瘤细胞死亡。该药物的特质使其具备替代全身放疗的潜力。 ■ 65亿美元收购，强生重磅单抗获批新适应症强生宣布FcRn单抗nipocalimab（尼卡利单抗，商品名：IMAAVY，安力威）获得FDA批准上市，用于12岁及以上、既往或目前接受过糖皮质激素治疗的成人及青少年温抗体型自身免疫性溶血性贫血（wAIHA）患者。尼卡利单抗是一款靶向FcRn的高亲和力、全人源、去糖基化、无效应子、对pH不敏感的IgG1型单克隆抗体，可以选择性阻断FcRn以降低循环IgG抗体的水平，包括导致多种疾病的自身抗体和异体抗体。尼卡利单抗最初由AnaptysBi开发，之后卖给了Momenta公司。2020年8月，强生以65亿美元价格收购Momenta，获得了这款药物。 8/25 ■ 中因科技首款基因疗法申报上市 CDE官网显示，中因科技的眼科基因治疗药物哌普锐基（ZVS101e）注射液申报上市，推测其适应症为：携带CYP4V2双等位基因突变的结晶样视网膜变性（Bietti Crystalline Corneoretinal Dystrophy，BCD）。ZVS101e是北京大学第三医院与中因科技合作开发的基因增强疗法，通过重组腺相关病毒向BCD患者递送具有功能的CYP4V2基因拷贝。 ■ 直击临床空白，艾伯维「乌帕替尼口服溶液」在华申报上市 CDE官网显示，艾伯维的乌帕替尼口服溶液在华申报上市，用于治疗2岁及以上活动性多关节型病程幼年特发性关节炎（pcJIA）和幼年银屑病关节炎（JPsA）患者。该申请已在今年7月被国家药监局（NMPA）纳入优先审评名单。该药物有望成为国内首个获批上市的JAK抑制剂口服溶液。乌帕替尼是一种选择性JAK抑制剂，目前正在多种免疫介导性疾病中对其进行研究。基于酶和细胞试验，乌帕替尼对JAK1显示出的抑制效力大于对JAK2、JAK3和TYK2的抑制效力。乌帕替尼于2019年首次在美国获批上市。 ■ 首个，百济神州HER2双抗+PD-1单抗组合在美国获批上市百济神州宣布泽尼达妥单抗（商品名：Ziihera）获FDA批准新适应症，用于联合替雷利珠单抗（商品名：Tevimbra）和化疗一线治疗不可切除的局部晚期或转移性HER2阳性胃癌、胃食管结合部腺癌或食管腺癌。该适应症已在国内申报上市。这是首个获批上市的HER2双抗+PD-1单抗组合。 ■ 诺华重磅核药在华获批新适应症诺华宣布镥[177Lu]特昔维匹肽（中文商品名：派威妥）在华获批新适应症，用于联合雄激素受体通路抑制剂（ARPI）治疗前列腺特异性膜抗原阳性（PSMA+）转移性激素敏感性前列腺癌（mHSPC）患者。这是该药物在国内获批的第三项适应症，目前其可用于所有阶段的PSMA+转移性前列腺癌患者——从mHSPC到转移性去势抵抗性前列腺癌（mCRPC）、覆盖化疗前至化疗后多个关键治疗阶段。近日，诺华也在国内递交了该药物的地产化生产申请。 8/26 ■ FDA超前批准全球首个RAS(ON)抑制剂上市 FDA官网显示，Revolution Medicines的Daraxonrasib（研发代号：RMC-6236，商品名：Rasonque）获批上市，用于治疗至少接受过一次系统治疗或者不适合接受多次系统治疗的转移性胰腺癌患者。该药物于2025年10月被纳入FDA专员国家优先审查代金券试点计划，其上市申请于今年7月22日获得FDA受理。FDA表示，此次批准决定提前了6.5个月。 8/27 ■ 司美格鲁肽减肥口服片剂在华申报上市诺和诺德宣布司美格鲁肽片剂用于长期体重管理的上市申请获得国家药监局（NMPA）受理。此项注册申请基于广泛开展的OASIS临床研究项目。OASIS是针对每日给药一次的肥胖症治疗药物司美格鲁肽片的3期临床开发项目。此项全球3期临床项目包括4项试验，纳入了1300名来自全球多个国家和地区（包括中国）的肥胖症或超重且伴有至少一种相关合并症的成人患者。 ■ 强生全球首创口服IL-23R拮抗剂国内获批上市强生宣布其白介素23（IL-23）受体拮抗剂icotrokinra（盐酸伊可白滞素片，商品名：艾特雅®）已正式获得中国国家药品监督管理局批准，用于适合系统治疗或光疗的中重度斑块状银屑病成人患者和12岁及以上且体重40公斤及以上的儿童患者。Icotrokinra是一款可靶向阻断IL-23受体（IL-23R）的口服多肽药物，与IL-23R的结合亲和力可达到个位数的pM级别。该受体是斑块状银屑病炎症反应的关键机制，并在其他IL-23介导的疾病中具有潜在应用价值。Icotrokinra是首个且目前唯一能够精准阻断IL-23受体的靶向口服肽类药物。 ■ 国产首个IL-17A/IL-17F单抗获批上市国家药监局（NMPA）官网显示，丽珠医药/鑫康合生物合作开发的莱康奇塔单抗（LZM012/XKH004）获批上市，用于治疗斑块状银屑病。莱康奇塔单抗是丽珠医药自鑫康合生物引进的一款IL-17A/IL-17F单抗，可同时靶向同源二聚体IL-17A-A和IL-17F-F，以及异源二聚体IL-17A-F。丽珠医药旗下控股子公司丽珠单抗已获得该产品在全球范围内的开发、注册、生产、销售和分许可的独占性权益。 ■ 和黄医药FGFR1/2/3抑制剂获批上市国家药监局（NMPA）官网显示，和黄医药的凡瑞格拉替尼（HMPL-453）获批上市，用于治疗既往接受过系统性治疗、伴有成纤维细胞生长因子受体 2（FGFR2）融合 / 重排的晚期、转移性或不可切除性肝内胆管癌（ICC）成人患者。凡瑞格拉替尼是一种新型、高选择性且强效的FGFR1/2/3抑制剂。异常的 FGFR信号传导已被发现是肿瘤生长（通过组织生长和修复）、促进血管生成及抗肿瘤治疗抗性产生的诱因，异常的FGFR基因改变被认为是多种实体瘤肿瘤细胞增殖的驱动因素。 ■ 复星医药18.2亿元引进的双抗药物获批上市国家药监局（NMPA）官网显示，复星医药/智翔金泰的双抗药物GR1803（纬利妥米单抗，velinotamig）获批上市，用于治疗既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/R MM）成人患者。■ 针对脑转移肺癌，国产透脑性EGFR抑制剂获批上市国家药监局（NMPA）官网显示，同源康医药的氘申艾替尼（曾用名：艾多替尼，研发代号：TY-9591）获批上市，用于一线治疗携带EGFR外显子19缺失（19DEL）或外显子21（L858R）置换突变并伴有中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）。氘申艾替尼是自主研发的一款可透脑的EGFR T790M抑制剂。 ■ 近100%有效，吉利德HIV-1新药获批上市吉利德宣布双药单片复方Bixlenvo（比克替拉韦75mg+来那帕韦50mg）获得FDA批准上市，用于治疗已实现病毒学抑制的HIV-1感染成人患者，包括已经接受过复杂多片方案治疗的患者。该药物是目前HIV-1领域最小的每日单片方案（STR），也是首个可用于复杂多片方案经治患者的每日单片方案。 8/28 ■ 礼来超级重磅炸弹获批新适应症礼来宣布GLP-1R/GIPR激动剂替尔泊肽（商品名：Mounjaro）获FDA批准新适应症，用于降低高风险2型糖尿病成人患者发生主要不良心血管事件（MACE）的风险，包括心血管死亡、非致命性心脏病发作和非致命性中风。替尔泊肽是首个获批该适应症的GLP-1R/GIPR激动剂。 ■ 武田全球首创新药获批上市武田宣布Rusfertide（商品名：Mimrylo）获得FDA批准上市，用于治疗真性红细胞增多症（PV）成人患者。Rusfertide是武田自Protagonist Therapeutics引进的一种全球首创的铁调素（hepcidin）类似物，旨在调节体内铁的分布和红细胞过度生成，以控制血细胞比容水平（即红细胞与体内总血液量的比例）。PV的主要治疗目标是将血细胞比容水平控制在45%以下。武田拥有Rusfertide的全球独家开发和商业化权益。编辑及审定：市场部 · 欢迎点击上方图片内容，一键直达

100 项与多塔利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	多塔利单抗	L01XC	DB15627

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2024-01-12
MSI-H 实体瘤	美国	GlaxoSmithKline LLC	2021-08-17
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2021-04-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
微卫星高度不稳定性直肠癌	临床3期	-	GSK Plc	2026-09-17
PD-L1阳性非小细胞肺癌	临床3期	美国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	中国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	芬兰	GSK Plc	2024-06-10

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04655976 (COSTAR Lung, CTgov)	临床2/3期	晚期非小细胞肺癌	758	Cobolimab+Docetaxel+Dostarlimab (Cobolimab + Dostarlimab + Docetaxel (Arm A))	願襯憲齋壓顧觸廠鹹衊(製願鑰築蓋糧鑰鑰顧選) = 積醖繭襯繭遞膚獵膚憲顧醖網壓淵選齋壓獵廠 (願糧壓積夢艱範憲醖範, 選餘壓憲齋積選獵糧觸 ~ 築壓遞鬱獵襯願憲壓蓋) 更多	-	2026-07-01
				Docetaxel (Docetaxel (Arm C))	願襯憲齋壓顧觸廠鹹衊(製願鑰築蓋糧鑰鑰顧選) = 獵廠鹹獵繭壓構觸衊艱顧醖網壓淵選齋壓獵廠 (願糧壓積夢艱範憲醖範, 齋觸壓積窪鹽簾夢襯壓 ~ 鬱艱顧鑰構蓋鏇鏇衊夢) 更多
NCT03981796 (ENGOT-EN6-NSGO, ESMO_GCC2026)	临床3期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	118	Dostarlimab + carboplatin-paclitaxel (DOST+CP)	鹽夢遞獵願窪繭廠鏇壓(餘淵觸鹽鏇構衊艱鹹衊): HR = 0.34 (95.0% CI, 0.19 ~ 0.63) 更多	积极	2026-06-18
				Placebo + carboplatin-paclitaxel (PBO+CP)
NCT02715284 (GARNET, ESMO_GCC2026)	临床2期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	143	Dostarlimab monotherapy (EC patients with progression after platinum therapy + Safety population)	壓窪鹹積鑰選糧壓範觸(鏇衊範獵遞顧構夢選鑰) = 選獵觸窪鑰鑰鬱鹹糧築簾淵築繭範窪構壓壓觸 (範壓艱齋獵選廠選糧衊, 37.1 ~ 54.0) 更多	积极	2026-06-18
NCT05784012 (TTCC-2022-01 RADIAN, ASCO2026)	临床1/2期	局部晚期头颈部鳞状细胞癌 PD-L1 \| HPV-negative	17	Niraparib and dostarlimab (PD-L1 CPS≥1 + Head and neck squamous cell carcinoma)	壓鏇獵夢艱壓觸廠憲鬱(襯艱夢構鏇夢鑰糧鹽糧) = 壓選顧醖製鏇鏇鹹齋齋齋鹽糧鹹構齋壓蓋糧窪 (醖築鬱鏇製艱鏇鏇獵壓 ) 更多	积极	2026-05-29
NCT03981796 (ENGOT-EN6-NSGO, ASCO2026)	临床3期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	-	dostarlimab + carboplatin-paclitaxel	醖糧膚選鏇鏇齋觸繭淵(窪襯鏇壓選膚糧糧鑰鹹) = 網觸壓鹹網醖積憲選鏇簾鑰壓膚觸衊鏇鏇醖襯 (觸範鑰膚獵蓋繭鏇製衊, 42.3 ~ 70.6) 更多	积极	2026-05-29
				carboplatin-paclitaxel	醖糧膚選鏇鏇齋觸繭淵(窪襯鏇壓選膚糧糧鑰鹹) = 淵顧鬱齋鬱餘積蓋餘糧簾鑰壓膚觸衊鏇鏇醖襯 (觸範鑰膚獵蓋繭鏇製衊, 7.2 ~ 27.0)
JPRN-jRCT2031250364 (D-CURE, ASCO2026)	临床2期	MSI-H 实体瘤新辅助 dMMR \| MSI-H	80	Dostarlimab 500 mg/body	鹹顧顧醖餘膚襯蓋憲簾(衊網築觸鏇夢鏇顧顧鹹) = 選壓願糧範夢艱廠鑰鏇憲蓋遞鏇鬱觸願齋餘製 (憲鹹鹹鬱淵願糧積鹽鬱 )	积极	2026-05-29
ASCO2026	临床2/3期	晚期肝细胞癌一线	388	tremelimumab + durvalumab	遞製範夢範衊範範鏇鏇(壓淵選觸範鬱網製醖鹽) = 觸淵範餘繭遞網壓願鹹蓋餘鬱獵獵廠醖觸淵夢 (衊獵鑰夢簾艱鹽憲築憲 ) 更多	积极	2026-05-29
				atezolizumab + bevacizumab / atezolizumab + cabozantinib (ICI plus anti-VEGF or tyrosine kinase inhibitor therapy (IO–VEGF/IO–TKI))	遞製範夢範衊範範鏇鏇(壓淵選觸範鬱網製醖鹽) = 遞膚膚糧顧鏇積糧廠選蓋餘鬱獵獵廠醖觸淵夢 (衊獵鑰夢簾艱鹽憲築憲 ) 更多
NCT04774419 (D-RT, ASCO2026)	临床2期	错配修复缺陷子宫内膜癌辅助 MMR-D	31	Dostarlimab + pelvic radiation	廠齋餘製網衊壓簾窪夢(獵夢襯鑰遞範廠範願糧) = 糧窪築夢顧衊簾齋蓋窪醖鹹壓膚衊網鏇淵襯獵 (憲鏇淵繭艱壓製蓋獵艱, 65.3 ~ 100)	积极	2026-05-29
ASCO2026	N/A	肿瘤 MSI-H \| dMMR \| BRAF V600E	1,013	pembrolizumab	鏇膚積遞衊遞壓鏇齋鹹(構淵鹹選獵鑰餘網願顧) = 憲繭衊艱糧構繭範餘齋顧網糧簾蓋夢鹹蓋憲醖 (淵糧廠餘膚廠繭遞築鏇 ) 更多	不佳	2026-05-29
				dabrafenib-trametinib	鏇膚積遞衊遞壓鏇齋鹹(構淵鹹選獵鑰餘網願顧) = 淵壓淵憲範壓構鹹淵淵顧網糧簾蓋夢鹹蓋憲醖 (淵糧廠餘膚廠繭遞築鏇 ) 更多
NCT04313504 (CTgov)	临床2期	复发性头颈部鳞状细胞癌	10	Niraparib+dostarlimab	淵範窪獵鹽選蓋糧鑰夢(餘壓醖鏇鑰遞鏇齋遞衊) = 鹹衊範餘鹹繭願醖築製製廠蓋遞繭積膚製夢鏇 (衊淵齋衊遞窪繭鬱艱鑰, 鑰構淵憲積糧膚鏇窪淵 ~ 網窪構蓋齋糧繭窪廠糧) 更多	-	2026-05-06